Cleared Traditional

Flap Fixator, Burr Hole Cover (K192310) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192310 · Ossaware Biotech Co., Ltd. · Neurology device
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Jun 2020
Decision
282d
Days
Class 2
Risk

K192310 is an FDA 510(k) clearance for the Flap Fixator, Burr Hole Cover. Classified as Cover, Burr Hole (product code GXR), Class II - Special Controls.

Submitted by Ossaware Biotech Co., Ltd. (Shenkang Hsiang, TW). The FDA issued a Cleared decision on June 3, 2020 after a review of 282 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5250 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ossaware Biotech Co., Ltd. devices

Submission Details

510(k) Number K192310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2019
Decision Date June 03, 2020
Days to Decision 282 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 148d · This submission: 282d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXR Cover, Burr Hole
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GXR Cover, Burr Hole

All 28
Devices cleared under the same product code (GXR) and FDA review panel - the closest regulatory comparables to K192310.
Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)
K253447 · Orthocon, Inc. · Mar 2026
Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System
K240137 · Neos Surgery S.L · Feb 2024
Absorbable Cranial Flap Fixation System
K221606 · Chendu Medart Medical Scientific Co., Ltd. · Nov 2023
NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate
K192162 · Neurovention, LLC · Mar 2020
OSSDSIGN Cranioplug
K181539 · Ossdsign AB · Oct 2018
GuardianTM Burr Hole Cover System
K181382 · St Jude Medical · Jul 2018